Use in Pregnancy (Category D): Women of child-bearing potential should be advised to avoid becoming pregnant during treatment and should use effective contraceptive methods.
There is no specific information available at present concerning the use of Pharmorubicin in human pregnancy. However, as it has been shown to be embryotoxic and fetotoxic in animals, it should not be used in patients who are pregnant or are likely to become pregnant.
Although no studies have been conducted with Pharmorubicin, it may be expected, like doxorubicin, to cause infertility during the period of drug administration. In women, Pharmorubicin may cause amenorrhoea. After termination of therapy, ovulation and menstruation may be expected to return in a few months, often accompanied by normal fertility. Premature menopause may also occur.
In male patients, oligospermia or azoospermia may be permanent, although fertility may return several years after ceasing therapy. Given the mutagenic potential of Pharmorubicin, the drug could induce chromosomal damage in human spermatozoa; therefore, males undergoing Pharmorubicin treatment should employ contraceptive measures.
Use in Lactation: It is likely that Pharmorubicin is excreted in breast milk, therefore, it is not recommended for nursing mothers unless the expected benefit outweighs any potential risk.